SIFClass II

Software Device System For Estimation Of Cardiac Pressures

21 CFR 870.1150 / Cardiovascular

SIF is the FDA product code for Software Device System For Estimation Of Cardiac Pressures, a class II device type, regulated under 21 CFR 870.1150. FDA's definition for this code reads: "This prescription-only device uses machine learning-based algorithms to analyze one or more non-invasive physiologic signals or parameters to estimate a cardiac pressure (e.g. pulmonary capillary wedge pressure, left ventricular end diastolic pressure, or pulmonary artery pressure.) This device is intended for...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2026-05-22, and no recalls.

Classification record

Product code: SIF
Device name: Software Device System For Estimation Of Cardiac Pressures
FDA definition: This prescription-only device uses machine learning-based algorithms to analyze one or more non-invasive physiologic signals or parameters to estimate a cardiac pressure (e.g. pulmonary capillary wedge pressure, left ventricular end diastolic pressure, or pulmonary artery pressure.) This device is intended for adjunctive use with patient information and is not intended to independently direct therapy. The device may contain hardware sensors. This device is not intended to estimate systemic, vascular blood pressure.
Regulation: 21 CFR 870.1150
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code SIF

By decision year

1 clearance under product code SIF with a decision year between 2026 and 2026, 2026 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code SIF by decision year
Year	Clearances
2026	1

Applicants with the most clearances

Product code SIF

Applicants holding the most 510(k) clearances under product code SIF
Applicant	Clearances
Cardiosense, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code SIF.

Recent clearances

Product code SIF

DEN250057Class IIPCWP Analysis SoftwareCardiosense, Inc. / cleared 2026-05-22

Recent recalls

Product code SIF

FDA records show no recalls under product code SIF.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)